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Completed

NCT Number: NCT04349033

Virtual Human Technology for Patients With Chronic Pain

The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.

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Key information

Conditions

Chronic Musculoskeletal Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California Center for Self-report Science

Los Angeles, California, 90089-3332, United States

About this study

Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic musculoskeletal Pain

Exclusion criteria

  • Non-English speaking

Treatment and study plan

Emotional Disclosure and Brain Education

Behavioral

Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain.

Emotional Disclosure Only

Behavioral

Patients are interviewed about a number of aspects of their lives, but without brain education

Pain Information Control

Behavioral

Patients are interviewed about their pain history and other basic, non-disclosure information about their health.

Primary outcomes

  1. Pain Intensity

    Time frame: Change from Baseline to 1-month follow-up

    Brief Pain Inventory (average of the 4 pain intensity rating items: highest, lowest, average, now). Range: 0.0 to 10.0 (higher = more severe pain)

Secondary outcomes

  1. Pain Interference

    Time frame: Change from Baseline to 1-month follow-up

    Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)

  2. Pain Stages of Change Questionnaire

    Time frame: Change from Baseline to 1-month follow-up

    Pain Stages of Change Questionnaire assesses readiness / motivation to engage in pain self-management. Sum of subscales of Contemplation + Action + Maintenance - Precontemplation; Range = 0 to 12; higher scores = more readiness to change

  3. Pain Catastrophizing Scale

    Time frame: Change from Baseline to 1-month follow-up

    Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)

  4. Emotional Distress

    Time frame: Change from Baseline to 1-month follow-up

    Self-rating of how "depressed," "anxious," "angry," and "guilty" participant was during last week on 0 to 4 scale. Ratings averaged; higher means = more distress

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • University of Southern California

Registry information

Official study title

Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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